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Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)

RecruitingNAAges 18 Years - anyAllKU Leuven
NCT06914245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment. The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine w

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📋 Eligibility rules (as published)
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * At least 18 years of age at the time of signing the Informed Consent Form (ICF). * Proficient in reading, comprehending, and conversing in Dutch. * Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer. Exclusion Criteria: * The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection. * Experienced fecal incontinence prior to undergoing surgery. * Are affected by neurological disorders affecting bowel function. * Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons. * Has a permanent stoma.
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What it tests

  • Electronic bowel diary
  • Faecal Incontinence Quality of Life questionnaire (FIQL)
  • EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
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Where

1 site
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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